BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2233549 · Received September 2, 2011

    Report

    Report Number
    2122870-2011-03225
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JLW
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION DEVICE AND CENTRIFUGATION INFORMATION HAVE NOT BEEN SUPPLIED TO DATE. PER THE COLLECTED PROSERVICE DATA, ALL THREE LEVELS OF TSH QUALITY CONTROL RESULTS WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THIS EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE PERFORMED A 25 REPLICATE PRECISION TEST ON EACH OF THE INSTRUMENT'S FOUR REAGENT PIPETTORS. NO ISSUES WERE NOTED. THE FSE DID NOT NOTE ANY HARDWARE ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-03216, 2122870-2011-03217, 2122870-2011-03218, 2122870-2011-03219, 2122870-2011-03220, 2122870-2011-03221, 2122870-2011-03222, 2122870-2011-03223, 2122870-2011-03224, 2122870-2011-03225.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT HIGHER THAN EXPECTED THYROID STIMULATING HORMONE (HTSH) RESULTS, BELOW THE NORMAL REFERENCE RANGE, WERE GENERATED ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR TEN PATIENTS. ACCESS HYPERSENSITIVE HTSH REAGENT (LOT 170013) AND ACCESS HTSH CALIBRATORS (LOT 018459) WERE USED IN CONJUNCTION WITH THE DXI 800 SYSTEM. THIS REPORT IS ONE OF TEN AND REPRESENTS THE RESULTS FOR PATIENT TEN. THE EXACT DATE ON WHICH THE ERRONEOUS PATIENT RESULT WAS GENERATED IS UNKNOWN AND WILL BE INFERRED AS (B)(6), 2011. SUBSEQUENT TESTING ON THE SAME INSTRUMENT GENERATED A RESULT OUTSIDE OF THE ASSAY'S STATED PRECISION CLAIM OF LESS THAN OR EQUAL TO 7%. ADDITIONAL TESTING ON AN ALTERNATE METHODOLOGY ALSO GENERATED A LOWER RESULT. THE INITIAL HTSH RESULT WAS REPORTED OUT OF THE LABORATORY AND WAS QUESTIONED BY THE CLINICIAN. WHILE THERE IS NO REPORT OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, THE EFFECT TO PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JLW BECKMAN COULTER, INC. DXI 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1